Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chang Gung Memorial Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Low Dose of MCRcI® stem cells. |
|
| Intermediate Dose | Experimental | Intermediate Dose of MCRcI® stem cells. |
|
| High Dose | Experimental | High Dose of MCRcI® stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCRcI® stem cells | Biological | Intra-Coronary Administration of MCRcI® stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | Number of adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricle stroke volume | Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml). | 12 months |
| End diastolic volume | Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jackson TK Liu, MD | Contact | +886921167980 | honyamedical@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Y Lee, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HONYA Medical Inc | Tainan | 74147 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Dose escalation.
Not provided
Not provided
Participant blind with dose.
| 12 months |
| Left ventricular ejection fraction (LVEF) | Calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). | 12 months |
| Severity of angina symptom using Canadian Cardiovascular Society grading. | Canadian Cardiovascular Society grading of angina pectoris is a classification system used to grade the severity of exertional angina. Scale ranges 0 ~ IV (most sever), with 0 Asymptomatic Angina, I Angina only with strenuous exertion, II Angina with moderate exertion, III Angina with mild exertion and IV Angina at rest. | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |